1. Imaging biomarker roadmap for cancer studies
- Author
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Gary Cook, Geoff J M Parker, Gordon C Jayson, Judith E. Adams, Andrew J. I. Jones, Edward F. Jackson, Paul S. Tofts, James P B O'Connor, Laurence P. Clarke, Nathalie Lassau, Sandra Collette, Bruno Morgan, Andrew C. Peet, Lalitha K. Shankar, Fiona J. Gilbert, Ricky A. Sharma, Kevin M. Brindle, Ting-Yim Lee, Sarah E. Bohndiek, Hugo J.W.L. Aerts, Ferdia A. Gallagher, John R. Griffiths, Andrew R. Reynolds, Martin O. Leach, Anwar R. Padhani, John Dickson, Steve Halligan, Ross J. Maxwell, Shonit Punwani, Eric O. Aboagye, John C. Waterton, Adrian L. Harris, Simon Walker-Samuel, Prakash Manoharan, Nandita M. deSouza, James Wason, Stuart A. Taylor, David L. Buckley, Caroline Dive, David J. Hawkes, Thomas E. Yankeelov, Brian Hutton, Gillian M. Tozer, Thomas L. Chenevert, Mike Partridge, Sigrid Stroobants, Dow-Mu Koh, Edward Leen, Sally F. Barrington, Erich P. Huang, Lisa M. McShane, Denis Lacombe, Kaye J. Williams, Ambros J. Beer, Corinne Faivre-Finn, Daniel C. Sullivan, Ashley M. Groves, Kenneth A. Miles, Otto S. Hoekstra, Robert J. Gillies, J. Michael Brady, Simon P. Robinson, Gina Brown, Vicky Goh, Tony Ng, Jeffrey L. Evelhoch, Mark F. Lythgoe, Yan Liu, Ronald Boellaard, Alan Jackson, Dmitry Soloviev, Marcel van Herk, Paul Workman, Arvind P. Pathak, Steve Morris, Jason S. Lewis, Philippe Lambin, Medical Research Council (MRC), Cancer Research UK, Engineering & Physical Science Research Council (EPSRC), US Army (US), National Institute for Health Research, Scottish Power Foundation, Pfizer Limited, Commission of the European Communities, Imperial College Healthcare NHS Trust- BRC Funding, GlaxoSmithKline Services Unlimited, Bohndiek, Sarah [0000-0003-0371-8635], Gallagher, Ferdia [0000-0003-4784-5230], Gilbert, Fiona [0000-0002-0124-9962], Griffiths, John [0000-0001-7369-6836], Morris, Stephen [0000-0002-5828-3563], Wason, James [0000-0002-4691-126X], Brindle, Kevin [0000-0003-3883-6287], Apollo - University of Cambridge Repository, Guided Treatment in Optimal Selected Cancer Patients (GUTS), Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), and Biomedical Engineering and Physics
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Research design ,medicine.medical_specialty ,Pathology ,Imaging biomarker ,Standardization ,Cost-Benefit Analysis ,CELL LUNG-CANCER ,Clinical Decision-Making ,MEDLINE ,HIGH FAMILIAL RISK ,Article ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,CONTRAST-ENHANCED MRI ,0302 clinical medicine ,Breast cancer ,Folic Acid ,POSITRON-EMISSION-TOMOGRAPHY ,Fluorodeoxyglucose F18 ,Neoplasms ,Biomarkers, Tumor ,Medicine ,BREAST-CANCER ,Humans ,Medical physics ,GROUP DEVELOPMENTAL PATHWAY ,DRUG DEVELOPMENT ,Selection Bias ,Accreditation ,business.industry ,Reproducibility of Results ,Organotechnetium Compounds ,medicine.disease ,Prognosis ,3. Good health ,Clinical trial ,Oncology ,Drug development ,Research Design ,ADVANCED SOLID TUMORS ,030220 oncology & carcinogenesis ,Positron-Emission Tomography ,Human medicine ,Radiopharmaceuticals ,business ,SURROGATE END-POINTS ,CLINICAL-TRIALS ,Biomarkers - Abstract
Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing 'translational gaps' through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored 'roadmap'. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use.
- Published
- 2016
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